Blister track inhaler device having a separate end path and methods of use thereof

ABSTRACT

Embodiments of an inhaler device include a housing, a withdrawing assembly disposed within the housing for facilitating withdrawal of medicament from a target blister of a blister strip, the withdrawing assembly including an opening element adapted for opening the target blister of the blister strip while the target blister is positioned in the withdrawing assembly, and a dispensing element adapted for directing the withdrawn medicament toward the exterior of the inhaler device. A blister track is disposed within the housing for guiding each blister of the blister strip to the withdrawing assembly in succession, an advancing mechanism for advancing the blister strip by a predetermined distance each time the advancing mechanism is engaged, and an engaging element for engaging the advancing mechanism to advance the blister strip. The blister track includes a primary coil structure, a secondary coil structure, and a tertiary coil structure.

FIELD OF THE INVENTION

The present invention relates to an inhaler device for pulmonarydelivery of medicaments, and particularly to an inhaler device thatutilizes a blister strip that includes a plurality of blisterscontaining a powdered medicament.

BACKGROUND

It is often desirable or convenient to deliver a medicament to a patientpulmonarily, using a dispensing device, such as an inhaler device (orsimply, an “inhaler”). The inhaler device may be adapted to dispense aproduct, for example a medicament dose, from blisters within which adiscrete dose of a medicament is stored. This is particularly the casefor inhalers where the medicament is typically in a powdered form to beinhaled by a patient. Conventionally, blister-based unit dose inhalersuse blister packs having only a single blister cavity which may beinserted, opened, and the medicament inhaled therefrom. However, suchsingle dose inhalers may not be convenient for all patients sinceadditional individual blisters must be carried with the inhaler deviceany time a patient will need to use multiple doses over a period oftime. Additionally, unit dose inhalers require the patient to locate,manipulate, insert and remove the blister each time a medicament dose isdesired.

Accordingly, multiple dose inhalers that use a blister strip have beendeveloped. In such inhalers, the blister strip has a plurality ofblisters thereon and the strip is moved (longitudinally or rotationally)so that blisters are sequentially presented to a dispensing positionfrom which the medicament may be dispensed to the patient, such asduring inhalation. The blisters are opened when they are positioned inthe dispensing position, or as they are moved to the dispensingposition.

Some medicaments or inhalers may use blisters that are comparativelylarge, and in such cases, arranging the blisters in blister strips mayresult in a device which is unacceptably large, inconveniently shaped,overly cumbersome to use, and/or contain too few doses of medicament tobe widely accepted by patients.

In some inhaler devices, as blisters exit the inhaler device on theblister strip, the blisters must be removed and/or disposed of bycutting or tearing the blister strip, which is not considered apreferred patient use scenario. This is because the used blisters on theblister strip may hinder operation of the device, or may become ahindrance as they accumulate along with the device, or may disperseremaining medicament to locations exterior of the inhaler device, etc.,any of which are not acceptable to patients.

In other inhaler devices, a single or dual take-up reel may be used tocoil up used blisters in the interior of the inhaler device. However,these inhaler devices must be larger to account for the additional spacenecessary to house the used blisters.

In addition, since inhaler devices may be used by patients of all ages,strengths, and capabilities, it is useful that the inhaler deviceprovide uniform and easy operation from the first blister to the last,including installation and removal of blister strips from the inhalerdevice. Some older and/or frailer patients may not have the requisitestrength to operate an inhaler device in some operating conditions thata younger or stronger patient may be able to operate. However, each ofthese patients, irrespective of relative physical attributes (that isover a range of physical attributes) should be able to operate theinhaler device with equal ability regardless of the blister stripposition in the inhaler device.

SUMMARY

Accordingly, one embodiment of the invention comprises an inhaler devicecomprising a housing, a withdrawing assembly disposed at least partiallywithin the housing being adapted for facilitating withdrawal ofmedicament from a target blister of a blister strip and conveying themedicament toward an exterior of the inhaler device, a blister trackdisposed within the housing, the blister track being adapted for guidingeach blister of the blister strip to the withdrawing assembly insuccession and storing the blister strip prior to, during, and after useof blisters of the blister strip, an advancing mechanism disposed withinthe housing, the advancing mechanism being adapted for advancing theblister strip by a predetermined distance each time the advancingmechanism is engaged, and an engaging element adapted for engaging theadvancing mechanism to advance the blister strip, the engaging elementbeing operable by the user.

The withdrawing assembly includes an opening element adapted for openingthe target blister of the blister strip while the target blister ispositioned in the withdrawing assembly, wherein the opening element isoperable by a user, and a dispensing element adapted for directing thewithdrawn medicament toward the exterior of the inhaler device.

In some embodiments, the blister track comprises a primary coilstructure having a first radius, a secondary coil structure having asecond radius, a third radius, and a fifth radius, and a tertiary coilstructure having the second radius, a fourth radius, and the fifthradius.

In some embodiments of the present invention, an inhaler devicecomprises a housing; a withdrawing assembly disposed at least partiallywithin the housing, the withdrawing assembly being adapted forfacilitating withdrawal of medicament from a target blister of a blisterstrip and conveying the medicament toward an exterior of the inhalerdevice, wherein the withdrawing assembly comprises an opening elementadapted for opening the target blister of the blister strip while thetarget blister is positioned in the withdrawing assembly, wherein theopening element is operable by a user; and a dispensing element adaptedfor directing the withdrawn medicament toward the exterior of theinhaler device; a blister track disposed within the housing, the blistertrack being adapted for guiding each blister of the blister strip to thewithdrawing assembly in succession and storing the blister strip priorto, during, and after use of blisters of the blister strip, wherein theblister track comprises a primary coil structure comprising a firstradius, a secondary coil structure comprising a second radius, a thirdradius, and a fifth radius, and a tertiary coil structure comprising thesecond radius, a fourth radius, and the fifth radius; an advancingmechanism disposed within the housing, the advancing mechanism beingadapted for advancing the blister strip by a predetermined distance eachtime the advancing mechanism is engaged; and an engaging element adaptedfor engaging the advancing mechanism to advance the blister strip, theengaging element being operable by the user.

In some embodiments of the present invention, an inhaler devicecomprises a housing; a withdrawing assembly disposed at least partiallywithin the housing, the withdrawing assembly being adapted forfacilitating withdrawal of a medicament from a target blister of ablister strip and conveying the medicament toward an exterior of theinhaler device; and a blister advancing mechanism disposed within thehousing and adapted for advancing the blister strip from an initialposition where a leading edge of the blister strip is positioned in aprimary coil, to a final position where the leading edge of the blisterstrip is positioned in a secondary coil, wherein at least the leadingedge of the blister strip passes through the starting position of atrailing edge of the blister strip along the primary coil when theblister strip is advanced from the initial position to the finalposition.

In some embodiments of the present invention, an inhaler devicecomprises a blister track path and blister advance mechanism configuredfor providing a substantially consistent resistance to movement of theblister strip therethrough.

In some embodiments of the present invention, an inhaler devicecomprises a blister track path and blister advance mechanism configuredto provide to a user an approximately equal amount of resistance tooperation of the engaging element regardless of which blister of theblister strip is positioned as the target blister.

In some embodiments of the present invention, an inhaler devicecomprises, a blister track path and blister advance mechanism wherein anamount of resistance to operation of the engaging element for advancingthe blister strip past a first blister is about equal to an amount ofresistance to operation of the engaging element for advancing theblister strip past a final blister.

Other aspects and embodiments of the present invention will becomeapparent from the following detailed description, which, when taken inconjunction with the drawings, illustrate by way of example theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a simplified diagram of an inhaler device with a separateend path, according to one embodiment.

FIG. 2 shows schematics of a blister track with a separate end path ofan inhaler device with a blister strip in various positions, accordingto several embodiments.

FIG. 3A is an image of an inhaler device with a separate end path loadedwith a blister strip in a final position, according to one embodiment.

FIG. 3B is a detailed schematic of an inhaler device, according to oneembodiment.

FIG. 3C shows schematics of coil structures of a blister strip of aninhaler device, according to several embodiments.

FIG. 4A is a graphical representation of index wheel torque observedover the lifetime of an acetal-polymer inhaler device, according to oneembodiment.

FIG. 4B is a graphical representation of index wheel torque observedover the lifetime of a PBT-polymer inhaler device, according to oneembodiment.

FIG. 5 is a graphical representation comparing advancing mechanismtorque observed over the lifetime of an acetal-polymer inhaler deviceusing a continuous blister track without a separate end path versus aPBT-polymer inhaler device using a blister track having a separate endpath, according to one embodiment.

FIG. 6 is a schematic of a blister strip, according to one embodiment.

DETAILED DESCRIPTION

The following description is made for the purpose of illustrating thegeneral principles of the present invention and is not meant to limitthe inventive concepts claimed herein. Further, particular featuresdescribed herein can be used in combination with other describedfeatures in each of the various possible combinations and permutations.

Unless otherwise specifically defined herein, all terms are to be giventheir broadest possible interpretation including meanings implied fromthe specification as well as meanings understood by those skilled in theart and/or as defined in dictionaries, treatises, etc.

It must also be noted that, as used in the specification and theappended claims, the singular forms “a”, “an”, and “the” include pluralunless otherwise specified.

According to one general embodiment, an inhaler device comprises ahousing, a withdrawing assembly disposed at least partially within thehousing being adapted for facilitating withdrawal of medicament from atarget blister of a blister strip and conveying the medicament toward anexterior of the inhaler device, a blister track disposed within thehousing, the blister track being adapted for guiding each blister of theblister strip to the withdrawing assembly in succession and storing theblister strip prior to, during, and after use of blisters of the blisterstrip, an advancing mechanism disposed within the housing, the advancingmechanism being a blister advancing mechanism adapted for advancing theblister strip by a predetermined distance each time the advancingmechanism is engaged, and an engaging element adapted for engaging theadvancing mechanism to advance the blister strip, the engaging elementbeing operable by the user.

In some embodiments, the withdrawing assembly includes an openingelement adapted for opening the target blister of the blister stripwhile the target blister is positioned in the withdrawing assembly,wherein the opening element is operable by a user, and a dispensingelement adapted for directing the withdrawn medicament toward theexterior of the inhaler device. The blister track comprises a primarycoil structure having a first radius, a secondary coil structure havinga second radius, a third radius, and a fifth radius, and a tertiary coilstructure having the second radius, a fourth radius, and the fifthradius. It may be noted that the term “track” is generally used to referto the blister strip guiding structure in its entirety, while the term“coil” is generally used to refer to a subset structure of the track,however, a coil structure may also be referred to sometimes as a“track,” and vice versa.

In some embodiments, a multi-dose dry-powder inhaler comprises ahousing, a withdrawing assembly comprising an opening element and adispensing element, a blister track comprising multiple coil structures,an advancing mechanism, and an engaging element.

According to further embodiments, the multi-dose dry-powder inhaler mayalso comprise a blister track that minimizes one or more of the mean,maximum, and variability in torque experienced during blister stripadvancement along the blister track. The size of the blister trackremains relatively small compared to conventional blister tracks, andthe overall device size may accordingly be relatively small compared toconventional multi-dose dry-powder inhaler devices. For example, in oneembodiment the blister track may have dimensions of less than about 8.0cm by about 4.5 cm by about 2.5 cm and the inhaler device may haveoverall dimensions of less than about 12.0 cm by about 7.5 cm by about3.5 cm.

To minimize the space taken up by the blister strip during the course ofthe inhaler's useful life, the blister strip is kept within a blistertrack, in one embodiment. The blister strip is sequentially advanced oneblister forward at a time along the blister track to access each dose ofmedicament stored within each blister.

As shown in FIG. 1, in one embodiment the blister track may be arrangedsubstantially as blister track 100 is arranged, that as, comprising aprimary, secondary and tertiary coil structure. A discontinuous blisterstrip may be used in combination with the blister track 100 having acontinuous path 102 and a separate low-torque end path 104, according toone embodiment and as shown in FIG. 1. Such arrangement of elementsserves to reduce the peak torque experienced by the user during blisterstrip advancement. Notably, when the leading edge of the blister strip(which in the Figure, travels clockwise around the blister track 100)reaches the first junction 105, the blister strip may either enter theseparate low-torque end path 104 or continue along the continuous path102. However, less force is required to drive the blister strip intothis low-torque end path 104 than to drive the blister strip furtherinto the continuous path 102 of the blister track 100. Accordingly inembodiments of the invention, the blister strip is preferentiallydirected to the low-torque end path 104. Similarly, when the blisterstrip reaches the second junction 106, it may either continue along thelow-torque end path 104 or return to the continuous path 102. Onceagain, in embodiments of the invention, the blister strip is directed tothe low-torque end path 104. Ultimately, this requires less torque to beapplied by a user to the advancing mechanism, as shown in the comparisonof FIG. 5, according to some embodiments.

Furthermore, the overall size of the blister track 100 may be reducedsuch that the entire blister track 100 fits within an area defined by awidth D1 and a length D2, according to various embodiments. Of course,there is also a depth which is not shown in the two dimensionalrendering, but the blister track 100 may also be defined by this depth.In some embodiments, the blister track may have dimensions of a lengthD2 of less than about 8.0 cm by a width D1 of less than about 4.5 cm bya depth of less than about 2.5 cm. Of course, other dimensions arepossible, as would be understood by one of skill in the art, such asabout 7.9 cm×4.1 cm×2.2 cm, in one approach.

In addition to having a continuous path 102 and low-torque end path 104,various embodiments of the blister track 100 include three main coilstructures defined by one or more radii of various turns in the blistertrack 100.

For example, as shown in FIG. 3C, the blister track 100 includes aprimary coil structure 108 comprising a first radius R1, a secondarycoil structure 110 comprising a second radius R2, a third radius R3, anda fifth radius R5, and a tertiary coil structure 112 comprising thesecond radius R2, a fourth radius R4, and the fifth radius R5. Theserespective radii may be further characterized by the relationships shownbelow in Equations 1-4, according to several embodiments.

R5>R1   Eq. 1

R1>R4   Eq. 2

R4>R3   Eq. 3

R3>R2   Eq. 4

In some embodiments, the respective arcs of the blister track 100 (shownin FIG. 1) have coinciding center points from which radii R3-R5 emanate.In some embodiments, the blister track 100 and/or coil structures arepartially defined by radii of arcs that do not have coinciding centerpoints, as would be appreciated by one having ordinary skill in the artupon reading the present descriptions.

In other words, the blister track 100 may be characterized in someembodiments as including a feeding path (which may include the secondarycoil structure and a portion of the primary coil structure) adapted forstoring the blister strip prior to blisters of the blister strip passingthrough the withdrawing assembly and a return path (which may includethe tertiary coil structure and a portion of the primary coil structure)adapted for storing the blister strip after blisters of the blisterstrip have passed through the withdrawing assembly, where a portion ofthe feeding path is shared by a portion of the return path (such as atleast the primary coil structure).

In addition, after the return path diverges from the feeding path, thereturn path allows used blisters on the blister strip to travel in aturn direction consistent with that of the feeding path immediatelyprior to a transition to the return path, e.g., if the feeding pathwraps clockwise at this transition, the return path wraps clockwise, andvice versa. This aids in maintaining a low resistance to movement of theblister strip through and along the blister track 100.

Furthermore, in some embodiments of the present invention, a blisterstrip having used blisters thereon follows a different path (e.g., thereturn path) than a blister strip having unused blisters thereon (e.g.,the feeding path). That is to say, in one approach, any given blisterdoes not follow the same path on the blister track 100 twice.

Some embodiments of the blister track 100 have a geometry such that atthe very end of the return path, the blister strip having used blistersthereon runs head on into another portion of the blister strip havingused blisters thereon. Guidance of the beginning of the blister striphaving used blisters thereon is provided by the motion of the otherportion of the blister strip having used blisters thereon that itcontacts, rather than being controlled by direct contact with the trackwalls of the blister track 100, in one approach. This geometry allowsthe blister strip to move the last few millimeters along the blistertrack 100 without increasing the overall size of the blister track 100,and keeps the resistance to movement low.

In some embodiments, the path of the blister track 100 may be configuredto provide a substantially consistent resistance to movement of theblister strip therethrough. That is to say, the amount of resistancethat the blister strip experiences as it moves through the blister track100 is within about ±20% of a resistance value regardless of theposition of the blister strip in the blister track 100. In someembodiments, the resistance value is a peak value or a nominal value ora predetermined datum value. In some embodiments, the resistance valuetolerance is within about ±15% or ±12% or ±10% or ±8% of a resistancevalue.

According to some embodiments, the blister track 100 is configured toallow for a consistent torque profile while the advancing mechanismpulls blisters of the blister strip from the feeding path of the blistertrack 100 and pushes blisters of the blister strip toward and along thereturn path of the blister track 100. Preferably, this torque profile islower than in conventional inhaler devices, such that a user experiencesa low resistance to movement of the blister strip along the blistertrack 100.

In some embodiments, the user experiences about an equal amount ofresistance to operation of the engaging element regardless of whichblister of the blister strip is positioned as the target blister in thewithdrawing assembly, hence the resistance to movement is generallyconsistent.

In some embodiments, the user experiences both a low and consistentamount of resistance to movement of the blister strip and/or engagingelement.

In some embodiments, an amount of resistance to operation of theengaging element (described in more detail in reference to FIG. 3B) foradvancing the blister strip past a first blister is about equal to anamount of resistance to operation of the engaging element for advancingthe blister strip to a final blister.

Referring to FIG. 1, according to one embodiment the curvature of thearcs comprising radii R1, R2, R3, R4, and R5 may change uniformly ornon-uniformly along the arcs, in some approaches. However, in someembodiments, the change in curvature of the blister track 100 isgradual.

Referring now to FIG. 2, positions of an exemplary discontinuous blisterstrip 202 along a blister track 100 is shown at various stages ofadvancement of the blister strip 202, in some approaches. According tovarious embodiments, the discontinuous blister strip 202 may becharacterized by a discrete leading edge 208 and trailing edge 209.Arrow 204 indicates direction of blister strip 202 travel, according toone embodiment.

As shown at the left of FIG. 2 and according to one embodiment, theblister strip 202 is placed in an initial position (shown in FIG. 2 asINITIAL) prior to the delivery of any medicament to a user oradvancement of the blister strip 202. According to various embodiments,while in the initial position, the first blister in the blister strip202 may be positioned in the withdrawing assembly 206 and the leadingedge 208 of the blister strip 202 may be positioned just past thewithdrawing assembly 206.

In one embodiment, this first blister may be a blank, e.g., it maycontain no medicament. This allows a trained technician or automatedprocess to operate the advancing mechanism of the inhaler device toposition a blister which does not contain medicament into thewithdrawing assembly 206 for performing release testing, e.g., measuringa pressure drop with a simulated inhalation, button push force (topierce the target blister positioned in the withdrawing assembly 206),and/or cap closing force (to advance the blister strip) withoutcontaminating the device with medicament powder.

In some embodiments, the inhaler device may be delivered to a user withthe blank blister positioned in the withdrawing assembly 206 so thataccidental discharge of the medicament will not take place (since thefirst blister contains no medicament).

As shown in FIG. 2, as the blister strip 202 sequentially places a firstblister all the way to a last blister in the withdrawing assembly 206,the blister strip 202 advances through the blister track 100. Thecentral portion of FIG. 2 shows the blister strip 202 in an intermediateposition (shown in FIG. 2 as INTERMEDIATE) when a blister in-between thefirst blister and the last blister is positioned in the withdrawingassembly 206.

Now referring to the right-most portion of FIG. 2, the blister strip 202is shown in a final position (shown in FIG. 2 as FINAL), where the finalblister is positioned in the withdrawing assembly 206, and the leadingedge 208 of the blister strip 202 is positioned in the tertiary coilstructure, while the trailing edge 209 of the blister strip 202 ispositioned just prior to the withdrawing assembly 206.

Of course, FIG. 2 shows examples of how the blister strip 202 may movethrough the blister track 100, according to one embodiment. Otherconfigurations and arrangements are possible, as would be understood byone of skill in the art. However, the movement of the blister strip 202through the blister track 100 as described has significant advantagesover other configurations, including reduced torque requirement formovement of the blister strip 202 through the blister track 100, a moreconsistent torque profile (as is also evident from FIGS. 4A-4B), andreduced overall blister track 100 size, among other advantages.

Notably, as the blister strip 202 advances along the blister track 100,the portion of the blister strip 202 that has advanced beyondwithdrawing assembly 206 is pushed along the blister track 100, whilethe portion of the blister strip 202 preceding the withdrawing assembly206 is pulled along the blister track 100. This is an advantage overconventional inhaler devices, and in particular compared to inhalerdevices which rely exclusively on either pushing or pulling forces toadvance the blister strip 202 along its intended path (e.g., the blistertrack 100). For example, the inhaler device described herein accordingto various embodiments requires no additional leader or trailer on theblister strip 202 to engage the advancing mechanism. In embodiments ofthe invention, there is a single location of motive force that isco-located with the target blister using a single reel design. Inaddition, assembly is easier, because a leader does not need to bethreaded onto a spool (or multiple spools).

Referring again to FIG. 2, as the blister strip 202 progresses along theblister track 100, it eventually encounters junction 105 where it mayproceed either along the continuous path 102 or the low-torque end path104 as described above and shown in FIG. 1. Because the low-torque endpath 104 is the path of least resistance for the blister strip 202 whenthe leading edge 208 is located at junction 105, the leading edge 208enters the low-torque end path 104, subsequently resting in anintermediate position along the blister track 100 as shown in FIG. 2.Once it has entered the low-torque end path, the blister strip 202continues advancing along this path until all medicament has beendispensed from the inhaler device, eventually arriving in the finalposition (FINAL), according to one embodiment.

Upon each engagement of the advancing mechanism by the engaging element,the blister strip 202 is moved by a distance along the blister track100. In one embodiment, the distance may be predetermined such that itis sufficient to position a next blister in the withdrawing assembly206. Of course, other distances are possible, such as variable distancesaccording to blister placement, partial advancement of blisters,multiple blisters for each advancement, etc.

As is shown in FIG. 2, in some embodiments, the blister strip 202 isadvanced through the blister track 100 using a single motive source,such as an advancing mechanism in one approach, that pulls the blisterstrip 202 such that unused blisters on the blister strip 202 are pulledto the withdrawing assembly 206 while used blisters on the blister strip202 are pushed away from the withdrawing assembly 206.

The blister track 100 is configured such that the used blisters on theblister strip 202 are easily pushed along the blister track 100. Morespecifically, the blister return path uses one or more splines (whichmay be defined as variable radius curves in one approach) to easemovement of the blister strip 100 into and through the curvature changesof the splines. The curvature of the splines, in some embodiments, iskept constant at the transition points of the splines (which may bedefined as an initial point of entry into the spline from a section ofthe blister track immediately preceding the spline), and then graduallygets tighter or looser to optimize the space available within theinhaler device. The shape of the return path is an important aspect ofthe inhaler device, in some approaches, because it allows for aconsistently low torque profile across the range of movement of theblister strip 202 along the blister track 100.

Now referring to FIG. 3A, an image of an inhaler device with a separateend path loaded with a blister strip 202 in a final position is shown,according to one embodiment. As can be seen from this image, the leadingedge 208 of the blister strip 202 may contact or come close tocontacting the blister strip 202 at a point near an intersection of thesecondary and the tertiary coil structures. FIG. 3B shows an engagingelement and details of the withdrawing assembly, according to oneembodiment. FIG. 3A also shows a portion of the advancing mechanism 220,according to one embodiment.

In some embodiments, a first blister 212 in the blister strip 202 maycontain medicament, in which case the blister strip 202 may have aplurality of blisters 210, such as 31 blisters 210, one for each day ofa 31-day month. In months that include less than 31 days, the inhalerdevice may be disposed of with blisters 210 remaining in a positionprior to the withdrawing assembly 206 and/or unopened. When the firstblister 212 does not contain medicament, there may be 32 blisters 210present on the blister strip 202 to account for each day of a 31-daymonth, plus the blank first blister 212. It may be particularlyadvantageous to use an empty first blister 212 to verify expectedoperation of the inhaler device. For example, an empty first blister 212may be utilized to test performance of the opening element, thedispensing element, the engaging element, and/or the advancing mechanism220, along with positioning of the blister strip 202 within the inhalerdevice, in various approaches.

FIG. 3B shows a simplified schematic diagram of an inhaler device 300,according to one embodiment. As shown, the inhaler device 300 comprisesa housing 302, a withdrawing assembly 206 disposed at least partiallywithin the housing 302, the withdrawing assembly 206 being adapted forfacilitating withdrawal of medicament from a target blister 320 of ablister strip 202 and conveying the medicament toward an exterior of theinhaler device 300. The withdrawing assembly 206 comprises an openingelement 304 adapted for opening the target blister 320 of the blisterstrip 202 while the target blister 320 is positioned in the withdrawingassembly 206. The opening element 304 is operable by a user. Thewithdrawing assembly 206 also comprises a dispensing element 306 adaptedfor directing the withdrawn medicament toward the exterior of theinhaler device 300.

Furthermore, the inhaler device 300 also comprises a blister track 100disposed within the housing 302, the blister track 100 being adapted forguiding each blister 210 of the blister strip 202 to the withdrawingassembly 206 in succession and storing the blister strip 202 prior to,during, and after use of blisters 210 of the blister strip 202. Theblister track 100 may comprise the coil structures as previouslydescribed, according to one embodiment. In addition, the blister track100 may comprise a low or very low friction material, such aspolycarbonate (PC), acrylonitrile butadience styrene (ABS), polybutyleneterephthalate (PBT), polyoxymethylene (POM) also referred to as acetalplastic, and other polymers as would be understood by one of skill inthe art, in various embodiments. Of course, the blister track 100 maycomprise other materials in combination with or without the plastic orpolymer, such as metals, resins, and/or other suitable materials.

The inhaler device 300 also comprises the advancing mechanism 220disposed within the housing 302, the advancing mechanism 220 beingadapted for advancing the blister strip 202 by a predetermined distanceeach time the advancing mechanism 220 is engaged, and an engagingelement 308 adapted for engaging the advancing mechanism 220 to advancethe blister strip 202, the engaging element 308 being operable by theuser.

For example, as can be seen in FIG. 3B, the inhaler device 300 includesthe housing 302. The housing 302 may comprise a plastic or polymermaterial, such as polycarbonate (PC), acrylonitrile butadience styrene(ABS), polybutylene terephthalate (PBT), polyoxymethylene (POM) alsoreferred to as acetal plastic, and other polymers as would be understoodby one of skill in the art, in various embodiments. In particular, thehousing 302 may comprise a material having a low or very low coefficientof friction. Of course, the housing 302 may comprise other materials incombination with or without the plastic or polymer, such as metals,resins, and other suitable materials. In FIG. 3B, the housing 302appears only behind the components of the inhaler device 300 in order toillustrate the other components of the inhaler device 300, but inoperation the housing 302 may include all the components of the inhalerdevice 300, in order to provide rigidity and protection to the inhalerdevice 300, among other functions. In some embodiments, the housing 302may include only some of the components, while other components may beexternal of the housing 302, such as all or a portion of the dispensingelement 306, in some approaches.

In some embodiments, the blister strip 202 may be discontinuous (e.g.,not a loop, having a starting and ending portion) and may have aconsistent pitch between centers of adjacent blisters 210, e.g., thedistance between each blister 210 on the blister strip 202 is the same.In some embodiments, the consistent pitch between centers of adjacentblisters of the blister strip 202 may be less than about 12 mm, such asless than 11 mm, or less than 10 mm or less than 9 mm or less than 8 mm.Some pitch, is however, important, and may depend upon characteristicsof the material used in the blister strip. Thus in some embodiments apitch is between 5 and 10 mm, such as between 6 and 9 mm. n someembodiments, the pitch may be about 8 and 9 mm. In some embodiments, theblister strip 202 may comprise 32 blisters 210 comprising 31 blisters210 having a medicament therein prior to withdrawal therefrom, and afirst blister 212 having no medicament therein.

In some embodiments and as shown in FIGS. 3A and 3B, the advancingmechanism 220 may be a wheel structure with a plurality of grooves ornotches defined by a plurality of teeth. Each tooth may be configured toaccept a blister 210 of the blister strip 202. In operation, theblisters 210 arranged along the blister strip 202 fit into the groovesor notches. Furthermore, the advancing mechanism 220 drives the blisterstrip 202 along the blister track 100 by rotating in a clockwisedirection (according to the perspective shown in FIG. 3B), therebypushing the leading edge 208 of the blister strip 202 while pulling thetrailing edge 209 of the blister strip 202 and requiring a relativelylow amount of torque in order to operate. In some embodiments, theadvancing mechanism 220 may comprise a track wheel positioned at apredetermined distance from the blister track 100 and adapted foradvancing the blister strip 202 along the first radius of the primarycoil structure, such as by a distance (in some embodiments equal to thepitch) between centers of adjacent blisters.

According to some embodiments, the inhaler device 300 may optionallyinclude a counter mechanism (not shown) adapted for displaying a numberof blisters 210 in the blister strip 202 which have been opened or havenot been opened, e.g., the number of blisters 210 in the blister strip202 remaining, or alternatively, the number of blisters 210 in theblister strip 202 that have been opened/used.

In some embodiments, the housing 302 may comprise two pieces of astructure coupled together, such as a clamshell configuration, moldedplastic pieces, a top and bottom piece, etc., as would be understood byone of skill in the art upon reading the present descriptions. As shownin FIG. 3B, the housing 302 appears as a structure cut away above theshaded portion.

Referring again to FIG. 3B, in operation, the opening element 304breaches one or more surfaces of the target blister 320 and establishesa connection between the target blister 320 and the dispensing element306 via the withdrawing portion 206 of the inhaler device 300.Medicament contained within the target blister 320 may be conveyed fromthe target blister 320 toward the dispensing element 306 andsubsequently toward the exterior of the inhaler device 300. In oneparticular embodiment, the opening element 304 may include a hollowpiercing element adapted for piercing the target blister 320 andallowing withdrawal of medicament from the target blister 320 throughthe piercing element toward the dispensing element 306 and an operatingelement 322 adapted for causing the piercing element to engage thetarget blister 320 upon operation of the operating element 322.

In some embodiments, the dispensing element 306 may include one or morefluid configuration components, devices, elements or means to assist inenabling the patient's inspiratory efforts to evacuate and/or aerosolizethe medicament withdrawn from the target blister 320. Such components,devices, elements or means act to direct, shape, alter, or enhance airflow and/or air pressure. In some embodiments, the fluid configurationcomponents or means act to direct airflow at an angle to the blistersurface of between about 0 and 90 degrees. In some embodiments the fluidconfiguration components or means may comprise a venturi tube. In someembodiments the fluid configuration components or means may comprise oneor more vanes. In some embodiments, the dispensing element 306 maycomprise a mouthpiece adapted for conveying the withdrawn medicament ofthe target blister 320 toward the user. Any mouthpiece may be used asknown in the art, and the mouthpiece may be replaceable, removable,permanent, rigid, pliable, cleanable, etc., as would be understood byone of skill in the art. Moreover, the mouthpiece may include aplurality of outlets therein sufficient to direct the withdrawnmedicament of the target blister 320 to the user upon inhalation by theuser. In one such embodiment, two outlets may be provided within themouthpiece.

In operation, a user interacts with the inhaler device 300 to receive adelivery of medicament. For example, in one embodiment, the user mayoperate the opening element 304 of the withdrawing assembly 206, whichopens the target blister 320 positioned in the withdrawing assembly 206and permits medicament to flow from the target blister 320 to thedispensing element 306 within the withdrawing assembly 206 andsubsequently to the user. After receiving medicament, the user operatesthe engaging element 308, which may comprise a moveable cap 324 adaptedfor covering the mouthpiece in one embodiment. Upon user operation, theengaging element 308 engages the advancing mechanism 220 in order toadvance the blister strip 202 by a predetermined distance each time theadvancing mechanism 220 is engaged. Subsequent doses of medicament maybe accessed by repeating this process until all medicament has beendispensed from the inhaler device 300, e.g., the blister strip 202 hasbeen moved from initial position to final position.

The moveable cap 324 and housing 302 as shown in FIG. 3B are transparentin order to visualize the components contained therein and/or behind. Ofcourse, in practice the inhaler device 300 may utilize a moveable cap324 and/or housing 302 of any degree of transparency or opacity. Invarious embodiments, the moveable cap 324 and the opening element 304may be interlocked such that the moveable cap 324 engages the advancingmechanism 220 when the moveable cap 324 is transitioned from an openposition to a closed position only after the opening element 304 hasbeen operated. That is to say, the engaging element 308 only engages andoperates the advancing mechanism 220 after medicament has been dispersedfrom the inhaler device 300 and/or the target blister 320 has beenopened by the opening element 304.

According to some embodiments, the inhaler device 300 may have overalldimensions of less than about 12.0 cm by about 7.5 cm by about 3.5 cm.For example, as shown in FIG. 3B, a width D3 of the inhaler device 300may be less than about 7.5 cm, such as about 5.5 cm, in one approach.Furthermore, a length D4 of the inhaler device 300 may be less thanabout 12.0 cm, such as about 11.5 cm, in one approach. Although notshown in FIG. 3B, a depth (into the page) of the inhaler device 300 maybe less than about 3.5 cm, such as about 3.0 cm in one approach.

Referring now to FIG. 3C, the primary coil structure 108, the secondarycoil structure 110 and the tertiary coil structure 112 are shown onexemplary schematics of inhaler device blister tracks 100, according toone embodiment. As shown in FIG. 3C, the coil structure is illustratedas a heavier line overlaid upon the blister track 100. It should benoted that some portions of the blister track 100 may be shared by oneor more coil structures, in various embodiments. Of course, as would beunderstood by one having ordinary skill in the art and as describedpreviously, the blister track 100 may include additional and/oralternative coil structures without departing from the subject matter ofthe present invention. As previously indicated, there may be a differentnumber of coil structures (more or less) and/or the coil structures mayhave different shapes, overlapping portions, configurations, etc., aswould be understood by one of skill in the art upon reading the presentdescription.

Referring now to FIGS. 4A and 4B, graphical representations of data arepresented and show the torque required to advance the blister stripalong the blister track using the advancement mechanism over the life ofseveral exemplary embodiments of the inhaler device.

FIG. 4A shows data for the torque experienced over the life of aninhaler device as described herein using a blister track comprisingacetal copolymer. The y-axis represents the torque required to advancethe blister along the blister track, measured at the advancementmechanism, and the x-axis indicates the blister position, or indexnumber, present in the withdrawing assembly of the inhaler devicerequiring the torque to advance to the next position. Each of the curvesrepresents an entire blister strip passing through the device via theblister track, and generally indicate that the torque required toadvance the blister strip remains relatively constant in a range fromabout 7.5 Newton centimeters (N·cm) to about 15 N·cm, with twoadvancements out of about 320 (10 blister strips) requiring a maximumtorque of about 16 N·cm, according to various embodiments using ablister strip.

FIG. 4B shows data for the torque experienced over the life of aninhaler device as described herein using a blister track comprising PBT.As in FIG. 4A, the y-axis represents the torque required to advance theblister along the blister track, measured at the advancement mechanism,and the x-axis indicates the blister position, or index number, presentin the withdrawing assembly of the inhaler device requiring the torqueto advance to the next position. In FIG. 4B, each of the curvesrepresents an entire blister strip passing through the device via theblister track, and generally indicate that the torque required toadvance the blister strip remains relatively constant in a range fromabout 7.5 N·cm to about 17.5 N·cm, with two advancements out of 192 (6blister strips) requiring a maximum torque of about 21 N·cm, accordingto various embodiments using a blister strip comprising PBT.

Accordingly, in some embodiments a torque required to advance theblister strip is between about 6 and 20 N·cm, such as between about 6and 18 N·cm, or between about 7 and 15 N·cm. In some embodiments, atorque required to advance the blister strip varies from a first blisterto a last blister by no more than about 25%, such as no more than about20% or 18% or 15% or 10%.

Referring now to FIG. 5, a graphical comparison of torque required toadvance a blister strip along a prior art continuous loop blister trackcomprising acetal copolymer versus torque required to advance a blisterstrip along a discontinuous blister track comprising PBT is shown,according to one embodiment. As can be seen from FIG. 5, the torquerequired to advance the blister strip along the discontinuous track ismore stable (less variable) and lower than the torque required toadvance the blister strip along the prior art continuous loop blistertrack, especially in later advancements of blisters 21-32. Accordingly,the discontinuous blister strip and blister track of the inhaler devicedescribed herein according to various embodiments represents animprovement in the stability and overall reduction in the amount oftorque required to advance a blister strip along a blister track in aninhaler device.

According to one embodiment, and as shown particularly in FIG. 6, theexemplary blister strip 202 may include up to 31 active doses of amedicament, which may be contained within blisters 210 arranged on astrip 216, which may comprise any suitable material, such as foil, metalpolymer, flexible material, etc. In one embodiment, the blister strip202 may comprise fillets (particularly at the leading edge 208), whichmay reduce the torque necessary to advance the blister strip 202 throughthe blister track. In some embodiments, an additional first blister 212may be included nearest the leading edge 208 of the strip 216 for atotal of 32 blisters per discontinuous blister strip. In particular, theadditional blister 212 may be useful in operational testing of theinhaler device, for example to test the operation of the blister stripadvancement mechanism, the blister opening mechanism, the medicamentdelivery mechanism, etc., as would be understood by one having ordinaryskill in the art upon reading the present descriptions.

As shown in FIG. 6, each of the blisters 210 arranged along the strip216 are separated by a uniform distance D5 as measured fromcenter-to-center of adjacent blisters 210. In some embodiments, theblisters may be separated by a distance D5 of between about 7 mm and 9mm, such as about 8 mm.

The intended use of the discontinuous blister track is to guide theblister strip throughout the inhaler use life with a minimum blisteradvance torque mean, maximum, and variability, while also minimizing thetrack size.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Thus, the breadth and scope of a preferred embodiment shouldnot be limited by any of the above-described exemplary embodiments, butshould be defined only in accordance with the following claims and theirequivalents.

What is claimed is:
 1. An inhaler device, comprising: a housing; awithdrawing assembly disposed at least partially within the housing, thewithdrawing assembly being adapted for facilitating withdrawal ofmedicament from a target blister of a blister strip and conveying themedicament toward an exterior of the inhaler device, wherein thewithdrawing assembly comprises: an opening element adapted for openingthe target blister of the blister strip while the target blister ispositioned in the withdrawing assembly, wherein the opening element isoperable by a user; and a dispensing element adapted for directing thewithdrawn medicament toward the exterior of the inhaler device; ablister track disposed within the housing, the blister track beingadapted for guiding each blister of the blister strip to the withdrawingassembly in succession and storing the blister strip prior to, during,and after use of blisters of the blister strip, wherein the blistertrack comprises: a primary coil structure comprising a first radius; asecondary coil structure comprising a second radius, a third radius, anda fifth radius; and a tertiary coil structure comprising the secondradius, the fourth radius, and the fifth radius; an advancing mechanismdisposed within the housing, the advancing mechanism being adapted foradvancing the blister strip by a predetermined distance each time theadvancing mechanism is engaged; and an engaging element adapted forengaging the advancing mechanism to advance the blister strip, theengaging element being operable by the user.
 2. The inhaler device asrecited in claim 1, wherein the blister strip comprises a plurality ofblisters, and wherein the blister strip is discontinuous and has aconsistent pitch between centers of adjacent blisters.
 3. The inhalerdevice as recited in claim 2, wherein the advancing mechanism comprisesa track wheel positioned at a predetermined distance from the blistertrack and adapted for advancing the blister strip along the first radiusof the primary coil structure.
 4. The inhaler device as recited in claim1, wherein the dispensing element comprises at least one fluidconfiguration component adapted for conveying the withdrawn medicamentof the target blister toward the user.
 5. The inhaler device as recitedin claim 1, wherein the engaging element comprises a moveable capadapted for covering a mouthpiece, and wherein the engaging element andthe opening element are interlocked such that the engaging elementengages the advancing mechanism when the moveable cap is transitionedfrom an open position to a closed position only after the openingelement has been operated.
 6. The inhaler device as recited in claim 1,wherein the opening element comprises: a hollow piercing element adaptedfor piercing the target blister and allowing withdrawal of medicamentfrom the target blister through the piercing element toward thedispensing element; and an operating element adapted for causing thepiercing element to engage the target blister upon operation of theoperating element.
 7. The inhaler device as recited in claim 1, whereinthe path of the blister track is configured for providing asubstantially consistent resistance to movement of the blister striptherethrough.
 8. The inhaler device as recited in claim 7, wherein theuser experiences about an equal amount of resistance to operation of theengaging element regardless of which blister of the blister strip ispositioned as the target blister in the withdrawing assembly.
 9. Theinhaler device as recited in claim 1, wherein an amount of resistance tooperation of the engaging element for advancing the blister strip past afirst blister is about equal to an amount of resistance to operation ofthe engaging element for advancing the blister strip past a finalblister.
 10. The inhaler device as recited in claim 1, wherein theblister track comprises: a feeding path adapted for storing the blisterstrip prior to blisters of the blister strip passing through thewithdrawing assembly; and a return path adapted for storing the blisterstrip after blisters of the blister strip have passed through thewithdrawing assembly, wherein a portion of the feeding path is shared bya portion of the return path.
 11. The inhaler device as recited in claim10, wherein the blister track is configured to allow for a consistenttorque profile while the advancing mechanism pulls blisters of theblister strip from the feeding path and pushes blisters of the blisterstrip toward the return path.
 12. The inhaler device as recited in claim10, wherein the return path comprises one or more splines adapted foreasing movement of the blister strip into and through curvature changesof the one or more splines.
 13. The inhaler device as recited in claim12, wherein the curvature of each of the one or more splines is constantat a transition point and gradually tightens or loosens after thetransition point.
 14. The inhaler device as recited in claim 1, whereinthe fifth radius is greater than the first radius, wherein the firstradius is greater than the fourth radius, wherein the fourth radius isgreater than the third radius, and wherein the third radius is greaterthan the second radius.
 15. An inhaler device comprising a housing; awithdrawing assembly disposed at least partially within the housing, thewithdrawing assembly being adapted for facilitating withdrawal of amedicament from a target blister of a blister strip and conveying themedicament toward an exterior of the inhaler device; and a blisteradvancing mechanism disposed within the housing and adapted foradvancing the blister strip from an initial position where a leadingedge of the blister strip is positioned in a primary coil, to a finalposition where the leading edge of the blister strip is positioned in asecondary coil, wherein at least the leading edge of the blister strippasses through the starting position of a trailing edge of the blisterstrip along the primary coil when the blister strip is advanced from theinitial position to the final position.